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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. BONE WAX; STERILE NONABSORBABLE BONE WAX
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ETHICON INC. BONE WAX; STERILE NONABSORBABLE BONE WAX Back to Search Results
Catalog Number W810T
Device Problem Incomplete or Missing Packaging (2312)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4): to date, the device has not been returned.If the product is returned for evaluation, any further info derived from the evaluation will be submitted in a supplemental 3500a form.
 
Event Description
It was reported that the patient underwent an unknown procedure on unknown date and bone wax was used.Prior to use on the patient, sterile labeling was not found on primary packaging.Additional information has been requested.
 
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Brand Name
BONE WAX
Type of Device
STERILE NONABSORBABLE BONE WAX
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-BRAZIL
rodovia presidente dutra, km 1
54
sao paolo 12240 -908
BR   12240-908
Manufacturer Contact
guillermo villa
route 22 west po box 151
somerville, NJ 08876
9082180707
MDR Report Key5231021
MDR Text Key31449552
Report Number2210968-2015-18496
Device Sequence Number1
Product Code MTJ
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 11/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberW810T
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/02/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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